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Trial Title:
A Study to Assess Change in Disease State in Adult Participants With Acute Myeloid Leukemia (AML) Receiving Oral Venetoclax Tablets in Combination With Subcutaneously (SC) or Intravenously (IV) Injected Azacitidine in Colombia
NCT ID:
NCT05587049
Condition:
Acute Myeloid Leukemia
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Conditions: Keywords:
Acute Myeloid Leukemia
Venetoclax
Venclexta
Venclyxto
Azacitidine
ABT-199
Cancer
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Summary:
Acute myeloid leukemia (AML) is a cancer of the blood and bone marrow and is the most
common acute leukemia in adults. This study will evaluate how well venetoclax in
combination with azacitidine works to treat AML in adult participants in Colombia.
Venetoclax in combination with azacytidine is approved to treat Acute myeloid leukemia
(AML). All study participants will receive venetoclax in combination with azacitidine as
prescribed by their study doctor in accordance with approved local label. Adult
participants with a new diagnosis of AML will be enrolled. Around 70 participants will be
enrolled in the study in Colombia.
Participants will receive venetoclax tablets to be taken by mouth in combination with
azacitidine given by subcutaneous (SC) or intravenous (IV) injection according to the
approved local label. The duration of the study is approximately 36 months.
There is expected to be no additional burden for participants in this trial. All study
visits will occur during routine clinical practice.
Criteria for eligibility:
Study pop:
Newly diagnosed AML participants who are ineligible to intensive chemotherapy, that
starting treatment with Venetoclax in combination with azacytidine treated according to
the Colombia label.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Newly diagnosed acute myeloid leukemia (AML) defined as participants that have
histological confirmation of AML (de novo, secondary) by World Health Organization
(WHO) criteria, and have not received any prior treatment for AML.
- Ineligible to intensive chemotherapy due to >=75 years of age; or >=18 to 74 years
who have comorbidities that preclude use of intensive induction chemotherapy.
- Participants starting treatment with venetoclax in combination with azacytidine
treated according to the Colombia label and who are not completed the first cycle
(Cycle 28 days).
Exclusion Criteria:
- Participating in an interventional clinical trial within 30 days prior to Venetoclax
treatment initiation.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Sociedad de Oncologia y Hematologia del Cesar /ID# 248615
Address:
City:
Valledupar
Zip:
200001
Country:
Colombia
Status:
Recruiting
Facility:
Name:
Coorp Hosp Juan Ciudad Sede Hospital Universitario Mayor Mederi /ID# 248570
Address:
City:
Bogota DC
Zip:
111221
Country:
Colombia
Status:
Recruiting
Facility:
Name:
Fundacion Santa Fe de Bogota /ID# 248563
Address:
City:
Bogota
Zip:
11011
Country:
Colombia
Status:
Recruiting
Facility:
Name:
Clinica del Country /ID# 248430
Address:
City:
Bogota
Zip:
110231
Country:
Colombia
Status:
Recruiting
Facility:
Name:
Hospital Alma Mater de Antioquia /ID# 248562
Address:
City:
Medellin
Zip:
50010
Country:
Colombia
Status:
Recruiting
Facility:
Name:
Fundacion Valle Del Lili /ID# 248294
Address:
City:
Cali
Zip:
760032
Country:
Colombia
Status:
Recruiting
Facility:
Name:
Hospital Pablo Tobón Uribe /ID# 248569
Address:
City:
Medellín
Zip:
050034
Country:
Colombia
Status:
Recruiting
Start date:
November 30, 2023
Completion date:
August 31, 2025
Lead sponsor:
Agency:
AbbVie
Agency class:
Industry
Source:
AbbVie
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05587049
https://www.rxabbvie.com
